(45 days)
The Chemo-Spike II Reconstitution Device is indicated for use in the preparation and dispensing of lyophilized chemotherapy drugs in multiple dose vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel properly trained in aseptic procedures. The Chemo-Spike II Reconstitution Device is indicated for use prior to patient administration or physician use.
The Dispensing-Spike II Device is indicated for use in the preparation and dispensing of IV medication from multiple dose IV vials. The device is used to either add diluent to the vial or to withdraw medication from the vial. These medications and devices should be used by hospital medical personnel skilled and trained in maintaining asseptic technique. The Dispensing-Spike II is indicated for use prior to patient administration or physician use.
The Chemo-Spike II Reconstitution Devices has been designed for preparing and dispensing lyophilized chemotherapy drugs in vials. The device offers a sterile vent pathway, filtering the air, as well as a filtered pathway for the actual diluent or medication. The sterile vent protects the health care practitioner by releasing the vacuum from the drug vials during reconstitution with diluent. It also protects the patient by filtering microprecipitates and crystallizations. from the diluent after reconstitution.
The Chemo-Spike II Reconstitution Device consists of 2 filter media, a 5 micron hydrophilic filter for the actual medication (i.e. fluid) pathway and a 0.2 micron hydrophobic filter for venting the air pathway. Both filters are manufactured from PTFE (polytetrafluoroethylene) membrane and are housed in molded acrylic. The effective filtration area for the medication measures 1.0 cm2 while the effective vent area measures 4.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
The Dispensing-Spike II has been designed for preparing and dispensing multiple dose I.V. medication stored in rubber-stoppered vials. It is equipped with a sharp piercing spike and tight luer lock port with a hinged cap. The technician pierces the medication vial just once with the spike. A syringe, without a needle, should be affixed to the luer lock port. Repetitive injections into or aspirations from the multiple dose I.V. vial are made through the port of the spike device. This reduces the number of times the diaphragm of the vial is pierced.
The Dispensing-Spike II is equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway. The sterile vent protects the health care practitioner by helping to release the vacuum from the drug vials during reconstitution with diluent.
The Dispensing-Spike II is manufactured from PTFE (mentioned above) and molded acrylic. The effective filtration area measures 1.0 cm2. USP Class VI Plastics testing has been conducted on the device and has been found to be biosafe.
The provided documents describe two devices, the "Chemo-Spike II Reconstitution Device" and the "Dispensing-Spike II Device," and their 510(k) submissions to the FDA. However, these documents do not contain any information regarding specific acceptance criteria, device performance studies, or the methodologies typically associated with assessing the performance of AI/ML-based medical devices (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies).
These devices are physical medical accessories (a reconstitution device and a dispensing spike) designed for preparing and dispensing medications, primarily by filtering air and diluent/medication. The FDA review for these types of devices focuses on substantial equivalence to predicate devices, biocompatibility (USP Class VI Plastics testing), and sterility, rather than statistical performance metrics like sensitivity, specificity, or accuracy for diagnostic algorithms.
Therefore, I cannot provide the requested information for acceptance criteria and study details as it pertains to AI/ML device evaluation. The information below reflects what can be extracted from the provided text, which is limited to the device's function and a general statement about its safety and effectiveness relative to a predicate device.
1. Table of Acceptance Criteria and the Reported Device Performance
Based on the provided documents, explicit quantitative acceptance criteria and reported device performance in the context of diagnostic or AI/ML evaluations are not available. The device's "performance" is implicitly tied to its functional description and the assertion of "no new issues of safety and effectiveness" compared to predicate devices.
| Acceptance Criterion (Implicit based on device type) | Reported Device Performance (as stated in documents) |
|---|---|
| Chemo-Spike II Reconstitution Device: | |
| Sterile Vent Pathway Functionality | Provides a sterile vent pathway, filtering air (0.2 micron hydrophobic filter) to protect healthcare practitioners and patients. |
| Medication Pathway Filtration | Filters microprecipitates and crystallizations from diluent/medication (5 micron hydrophilic filter) to protect patients. |
| Biocompatibility | USP Class VI Plastics testing conducted and found to be biosafe. |
| Dispensing-Spike II Device: | |
| Sterile Vent Pathway Functionality | Equipped with a 0.2 micron polytetrafluoroethylene (PTFE) hydrophobic filter for venting the air pathway, protecting healthcare practitioners. |
| Reduction of Vial Piercings | Reduces the number of times the diaphragm of the vial is pierced for multiple-dose IV medication preparation. |
| Biocompatibility | USP Class VI Plastics testing conducted and found to be biosafe. |
| Substantial Equivalence to Predicate | Designed to be used in exactly the same manner as the predicate devices and introduces no new issues of safety and effectiveness. |
| Sterilization and Packaging (Dispensing-Spike II only) | The only change from the predicate is the method of sterilization and packaging, implying it meets previous sterilization efficacy. |
The following sections (2-9) are not applicable to the provided documents as they describe physical medical accessories and their 510(k) clearances, which do not involve AI/ML performance studies or ground truth establishment in the manner typically required for such algorithms.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. The documents do not describe performance studies involving test datasets for AI/ML algorithms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. Ground truth for diagnostic applications is not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or ground truth adjudication described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. These are not AI-assisted devices for interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for diagnostic purposes is relevant to these devices.
8. The sample size for the training set
- Not applicable. No training sets for AI/ML algorithms are mentioned.
9. How the ground truth for the training set was established
- Not applicable. No training sets or ground truth establishment process is described.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.